RecallDepth

SynchroMed II Infusion Pump. Product Number: 8637-20

Company
Medtronic Neuromodulation
Recall Initiated
September 11, 2024
Posted
October 21, 2024
Recall Number
Z-0137-2025
Quantity
1 unit
Firm Location
Minneapolis, MN

Reason for Recall

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

Distribution

US Nationwide distribution in the state of Mississippi.

Lot / Code Info

GTIN Number: 00643169630505. Serial Number: NGP004814H

Root Cause

Device Design

Action Taken

On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump.

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